BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SOMAVAC Drain Connector - Dual Output

    DI: 00850004219096 · Model: 10081 · SOMAVAC MEDICAL SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SOMAVAC Drain Connector - Dual Output
    Primary DI
    00850004219096
    Version / Model
    10081
    Catalog Number
    10081
    Company Name
    SOMAVAC MEDICAL SOLUTIONS, INC.
    Labeler DUNS
    080446796
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-18
    Public Version
    2
    Public Version Date
    2023-01-20
    Public Version Status
    Update
    Public Device Record Key
    28f6a8a6-c3d8-436f-8b85-a80d7b8248e5

    Device Description

    Sterile Drain Connector with a single input and two outputs.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

    GMDN Terms

    Code Name
    64512 Closed-wound drain connection tubing set

    Identifiers

    Type ID
    Primary 00850004219096
    Package 10850004219093

    Premarket Submissions

    Submission Number Supplement Number
    K180606 000